Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Unlocking Legalities: Overseas Practices, Park Doctrine Could Drive More Fraud Cases

Executive Summary

The US Department of Justice recently announced the largest-ever civil settlement in a device-related False Claims Act case. But otherwise it was a textbook FCA case, attorneys say, and many device companies still have a lot of work to do to ensure compliance and that their executives stay out of trouble. This is the first article in an occasional series in which Medtech Insight talks to attorneys to get the best takes on hot legal topics.

You may also be interested in...



FDA Memo Reiterates Off-Label Enforcement Policy

Pre-Trump agency memo on manufacturer communications about unapproved uses says new court rulings and studies on off-label uses and adverse reactions support restrictions; whether agency’s new leadership has the same view remains to be seen.

Shire To Pay Record-Setting Device FCA Settlement

The $350m settlement resolves False Claims Act allegations Shire and its subsidiaries used tactics including lavish meals, free medical equipment, unearned speaker payments and cash to encourage doctors to prescribe the company’s Dermagraft human skin substitute.

Vascular Solutions Case (Partially) Points Way Forward For Off-Label Marketing

Attorneys involved with a recent court ruling favoring Vascular Solutions believe the verdict might give manufacturers more latitude to engage in truthful, non-misleading, off-label speech. But caution is necessary.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL043624

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel